Category: Part 11

05 Nov 2018

5 Ways that CTMS Can Add Value to Organizations

Clinical Trial Management Systems offer essential functionality for tracking study visits, building a robust patient database, managing all study-related financials, and accelerating recruitment.

Over the last decade, the clinical research industry has seen an increase in the use of software systems to perform essential functions, increase efficiency, and reduce costs. Site-based CTMS systems play a large role in the move to advanced systems and processes that are re-shaping how research gets done.

How can CTMS add value to organizations?

  1. Recruitment Tools

Utilizing the vast number of recruitment tools within RealTime-CTMS enables sites to consistently meet enrollment goals and become a top-enrolling site. RealTime’s powerful features allow advertisement campaign integration with traditional media, Facebook, SubjectWell, website landing pages, and personalized mass study alerts.

  1. Build Your Database

With these advanced integration features, new study leads will flow into your CTMS database while simultaneously notifying staff. Staff can manage lead follow-up activity with attention to detail. With a robust database, sites can run detailed criteria searches to identify potential subjects for new studies. Be the first to screen and enroll qualified subjects.

  1. Improve Site Efficiency

From scheduling subjects, managing study documents, leading recruitment, and tracking study visits, to ensuring accurate accounting and timely sponsor payments; RealTime-CTMS will streamline the workflow of your site while ensuring critical site processes are maintained.

  1. Software Integration

Powerful integrations with other systems bring even more value to RealTime-CTMS.  For business development, RealTime can seamlessly connect to Devana Ignite for Sites.  For recruitment, integration can connect with Facebook, Instagram, SubjectWell, websites, Twilio and more. This will give you advanced recruitment tools that no other CTMS can offer.  Integrations with EMR/EHR systems can also streamline the flow of data between your hospital/medical practice and research activities in RealTime.  Embracing and cultivating new integration opportunities is just another way that RealTime is leading the CTMS market.

  1. Track Financials

Track study costs, reimbursements, and all other financials related to study activities with RealTime-CTMS. Subject stipends can also be easily loaded onto reloadable Visa/Mastercards with RealTime’s SitePAY solution.

Take your organization to the next level and add value to the clinical trial process from start to finish. Introducing CTMS, but more specifically, RealTime-CTMS can transcend organizational boundaries, improve efficiency, and act as a seamless portal for all site operations.

RealTime-CTMS can function on a single site, multi-site, or enterprise level. With add-on features such as eDOCS, eSOURCE, TEXT, and SitePAY, RealTime can deliver the one-and-only Site Operations Management System (SOMS) for an end-to-end solution.

To learn more about adding value to your organization with RealTime Software Solutions, call 210-852-4310, or visit www.realtime-ctms.com

24 Oct 2018

Key Takeaways from SCRS 2018

Assembling for a cause

Global Site Solutions has provided a centralized hub where sites, sponsors, and CROs can gather and network. For the past 12 years, Global Site Solutions Summit has given participants the opportunity to promote and build their business, share best business practices, attend insightful workshops and seminars, and develop new partnerships and relationships along the way.

Powerful words

In an eye-opening discussion with Shielia Nagley, she describes her husband’s constant battle with Alzheimer’s Disease and how they discovered the benefits of clinical research.

“Participating in research is the only way we can advance medicine.” -Shielia Nagley, advocate for husband and Alzheimer’s patient, Bill Nagley.

“You give us hope,” Nagley concluded, speaking to researchers, site directors, and those in between.

In a follow-up conversation with Rick Greenfield, we asked him a few questions on his takeaways from the conference.

RealTime-CTMS CEO, Rick Greenfield, speaks at Global Site Solutions Summit 2018 in Boca Raton, FL

How do you feel that RealTime is contributing to the advancement of medicine for patients like Bill Nagley?

“I feel that RealTime is a playing an increasingly important role by bringing advanced efficiencies for Sites, Sponsors and CROs with innovative software technologies such as eSOURCE, eRegulatory, CTMS, patient travel portals and so much more.  By improving the research process and increasing the flow of data and processes between all parties, we can find effective treatments and cures faster than ever before.”

What was your favorite part of the SCRS experience?

“Learning from and networking with all of the amazing professionals in our industry and  Seeing their excitement as my team would showcase the features and capabilities of our software solution.  We always receive great ideas for advancements that we take home to incorporate into future systems.”

Where do you see the clinical research in the next 5 years?

”Systems will connect with each other like never before and data will flow faster than ever. Advanced systems will not only create powerful integrations and increased efficiency but will greatly reduce errors and improve compliance. RealTime is very excited to be on the forefront of this change and to lead the charge to a powerful paperless future for our industry.”

Shannon, Ted, Elise, Nathan, and Rick from RealTime Software Solutions attended SCRS 2018.

If you missed RealTime at SCRS, our team is also attending MAGI West this October 21-24, 2018 in San Diego, California. Learn more about solutions including eSOURCE eDOCS, CTMS, TEXT,PAY and GlobalPAY that are leading our industry into the future.

Learn more about RealTime solutions HERE or call 210-852-4310 to speak to a RealTime expert!

12 Oct 2018

Benefits of MobileAPP Usage for Research Data Collection

We are living in an increasingly mobile and digital world.

The introduction of cellular phones, tablets, laptops, etc., has significantly impacted the efficiency of data flow, and signaled a dramatic shift from static information transfer to mobile platform usage, digital integration and cloud sharing.

Not only is this shift rapidly transforming communication methods within the general population, but also in the way that clinical research is conducted and documented. Mobile applications present a bright new future in data accuracy, safety and efficiency.

Mobile APPs are the next step in digital accessibility in clinical research.

According to the Pew Research Center, it is estimated that at least 95% of people in the U.S. own a cellular phone of some kind, with 77% of that group owning smartphones. This would indicate that more than likely, a majority of medical research team members own and actively use mobile devices.

The RealTime MobileAPP provides research teams with the ability to utilize this digital resource! With the Mobile APP, site staff and investigators have the ability to access necessary study information, collect data, review and sign documents and more from any place in the world with ease.

RealTime-MobileAPP provides cutting-edge features.

In addition to accessibility, the MobileAPP contains a number of innovative and comprehensive features, including:

  • Validated Part 11 compliance with mobile
  • User-friendly, comprehensive interface
  • Secure thumbprint signature technology
  • Contact management for site and sponsor contact information
  • eRegulatory file navigation
  • Patient recruitment and referrals tracking
  • Signature requests and notifications management
  • Completely mobile capabilities
  • Study document access
  • Secure password management

Join the forefront of digital research data collection!

Are you interested in joining the mobile technology movement? Contact our experts today at 210-852-4310, to learn how to take your software and business to the next level today!

 

10 Oct 2018

Major Clinical Trial Software Companies Announce Integration, Streamlining Site Operations

Major Clinical Trial Software Companies Announce Integration, Streamlining Site Operations

RealTime-CTMS and Devana Solutions® IGNITE for sites integrate, allowing sites to streamline the clinical trial process from study start-up, to close-out.

SAN ANTONIO, TX– The days of doing double work are over thanks to the integration of two clinical trial platforms RealTime-CTMS and Devana Solutions® IGNITE for sites.

Both companies are major players in the clinical trial software industry and have quickly grown in popularity among sites and sponsors across the globe. RealTime for its ever-popular eSOURCE solution along with its CTMS, eDOCS, TEXT and PAY products. Devana for its ability to streamline operations by automating study start-up, providing crucial study metrics and enhancing trial performance.

“Devana Solutions® IGNITE for sites robust study start-up tracking and data analytics platform integrated with RealTime’s simple and intuitive CTMS is a winning combination for a robust end-to-end solution for managing research site operations,” says Barry Lake, CEO & Co-Founder of Devana Solutions®. “Both parties are excited to announce the integration as we truly believe top research sites and networks will really benefit from the combination.”

The integration, already available for use, allows for a more streamlined approach to collecting data by eliminating the need to input critical study information into two separate systems. Essentially, all data entered into either system is automatically transferred and displayed in the other.

“RealTime’s ultimate goal is to enhance the overall performance of the clinical trial process with innovative technologies and meaningful integrations between systems,” says RealTime CEO, Rick Greenfield.  “Our integration with Devana fulfills this mission by creating a powerful integration that will bring two cutting-edge services together to save users time, improve performance metric tracking and reduce redundant data entry.”

This year, the companies are showing off their products and services at industry conferences and are offering users who take advantage of the integration a 10 percent discount off licensing fees for each system.

Both RealTime and Devana Solutions® IGNITE for sites have proven that innovation and staying ahead of the game can make all the difference.

To find out more about the integration of RealTime-CTMS and Devana Solutions®, visit https://www.realtime-ctms.com/integrations/devana/

 

About RealTime-CTMS:

RealTime-CTMS is a leader in cloud-based software solutions for the clinical research industry and is dedicated to solving problems and providing systems that make the research process more efficient and profitable.

About Devana Solutions:

Devana Solutions®, LLC is a SaaS provider driven by a core belief that data transparency through technology is critical to selection of the top performing research sites to align with pharmaceutical Sponsors and CROs to reduce drug development costs and cure disease.

03 Oct 2018

Power of Integration: SaaS

RealTime-CTMS believes in the power of integration

What is SaaS?
Software as a service offers many advantages over traditional software. Previously, people used floppy disks and CDs to install and update usable software on their computers. Downloading and updating software was a long and painstakingly endless process. That process has now evolved due to software being readily available for download via internet licensing.

SaaS in Clinical Research

SaaS has grown in popularity with the rise of software usage and cloud-based computing. With that in mind, there has been an inevitable need for software management systems in the clinical research industry. Companies like RealTime-CTMS and Devana Solutions® IGNITE FOR SITES allow for customers to purchase licenses rather than installing software the traditional way. Software solutions have never been easier to use and allow a less expensive alternative than traditional software.

The Benefits of Integration Between SaaS Vendors

The idea that any single software platform will serve all the needs of a business is simply not possible.  Many businesses utilize numerous software solutions to handle a wide range of business operations.  The downside of having to use different systems from different vendors is that users must constantly log in to different systems for these functions and often data shared between the systems must be double-entered into each system.  By integrating these systems, vendors of different software types can provide end-users with a whole new level of efficiency.  Data can be shared between the systems and greatly reduce the need to log in and out of the two systems on a regular basis.

Devana Solutions ® IGNITE FOR SITES and RealTime Integration

Devana Solutions ® IGNITE FOR SITES and RealTime Software Solutions are two powerful companies with leading SaaS technologies for clinical research operations. Both companies are major players in the clinical trial software industry and have quickly grown in popularity among sites and sponsors across the globe. RealTime for its ever-popular eSOURCE solution along with its CTMS, eDOCS, TEXT and PAY products. Devana for its ability to streamline operations by automating business development, study start-up activities, and reporting crucial study metrics.

This year, the companies are showing off their products and services at industry conferences and are offering users who take advantage of this game-changing integration a 10% discount off of licensing fees for each system. Learn more about this powerful integration HERE.

Make the switch to SaaS

Switching to SaaS solutions can provide many benefits to the clinical research process. RealTime-CTMS, eSOURCE, eDOCS, TEXT and SitePAY allow sites to easily manage all site operations. RealTime’s solutions allow Sites, Sponsors and CROs the ability to easily track documents, sign forms, manage studies, recruit subjects, and much more! Take your software and your business to the next level and speak to one of our experts today.

For more information on our software solutions, call 210-852-4310

15 Sep 2018

Data in Clinical Research

How electronic data is streamlining clinical research.

Major advancements in technology and cutting-edge software are drastically improving and reconstructing the way research is conducted. The collection of accurate data and information is providing a new perspective on the industry. So, how can electronic data simplify the research process? Let’s break it down.

Accuracy in data

First and foremost, the collected data should be 100% accurate and consistent for future use. Along with accuracy, data should comply with protocol specifics and requirements. For instance, not meeting the protocol-specifications may exclude a patient from the final database. Innovative software combined with accurate data can produce substantial efficiencies and increased precision in clinical trials.

Regulatory requirements

Maintaining an audit trail of data management activities is of vital importance. An audit trail ensures that every user can access only the allotted functions specific to that user. Collecting data on compliant software allows auditors to verify any discrepancies in the data management process.

Efficiency in the research process

Read, sign, done! Yes, it’s that easy. Utilizing software that allows anytime access to study-related data and documentation creates an effective result. Innovative technology along with accurate data is streamlining the research process, making it efficient for all parties (Sponsors, Sites, CROs, the FDA, and IRB).

With these advancements in software and technology, there is an uninventable shift from paper to software systems. RealTime offers innovative software to streamline the way data is collected. RealTime-eSOURCE benefits include:

  • Electronic Source Documents
  • Part II Compliant
  • Safe & Secure Cloud Hosting
  • eSignatures

 

Customized eSOURCE Templates

Build your own eSOURCE form templates that can be reused and/or modified on future studies, simplifying the eSOURCE creation process and saving time on each study.

Data Accuracy Assurances

Build data parameters into form fields to ensure completion, accuracy and eliminate errors. Protocol compliance checks and safety checks can be included to ensure subject eligibility.

Optimized for Multiple Platforms

RealTime-eSOURCE can be utilized on any type of device or display including desktops, laptops, or RealTime’s slick MobileAPP for Apple and Android operating systems.

Collaboration and Oversight

eSOURCE provides complete TEAM collaboration and real-time site monitoring utilizing web-based systems. A query system for CRAs streamlines communication and prevents data inconsistencies.

Efficient Integration Options

Pairing RealTime-eSOURCE with CTMS, eDOCS, TEXT and PAY offers efficient access to site systems and data like no other. Log into one RealTime system instead of many other systems to get the job done!

To learn more about eSOURCE or other RealTime-CTMS solutions, call (210) 852-4310

11 Apr 2018
what to look for in an eRegulatory system

Searching for an eRegulatory system? Here’s What to Look For

A few years ago, eRegulatory systems were nothing more than sponsor-fed trial master files requiring sites to complete double, and sometimes triple, the amount of work.  Anytime site regulatory personnel heard “electronic regulatory” they cringed at the idea of interrupting their day-to-day flow to maintain these systems in addition to their paper binders.

Due to these past experiences, the benefits of site-based eRegulatory systems were hard to imagine.  With the introduction of new technology and advanced software systems to support it, sites now have every opportunity to utilize eRegulatory systems to streamline regulatory processes, maximize cost-effectiveness, and make study information much more accessible to all parties like never before!

Why the change to eRegulatory?

The transition to eRegulatory in our industry can be largely attributed to advancements in technology and the “mobile revolution,” providing individuals access to the internet and advanced mobile features in the palm of their hands.  eRegulatory software has been designed to make clinical research more efficient by capturing electronic signatures, reducing the need for repetitive filing and clerical work, reducing paper and storage costs, and providing site’s consistency from study binder to study binder.

In the last few years, the industry’s attitude towards eRegulatory has shifted and now a rapidly growing number of sites embrace these new technologies to cut costs and increase efficiency. The development of innovative technology from mobile apps to user-friendly software has enabled sites and sponsors to save time and money while keeping all the important documents in one place, eliminating redundant tasks and reducing the possibility of human error. It is the combination of advanced technology and smarter software, that has allowed sites to truly move towards a paperless environment.

What should I look for in an eRegulatory system?

All eRegulatory systems are not the same.  Comparing the features and capabilities of systems is critical, so you have to know what to look for to make a good decision.  Below are some of the primary things to consider as you evaluate the various eRegulatory systems on the market:

User experience: User experience is one of the most important considerations when looking at systems. An eRegulatory system, designed to replace well-established paper systems, needs to provide an intuitive, efficient and user-friendly experience.   Everything from navigation, document upload, Outlook integration, drag-and-drop folder and document sorting are all features that make the user’s job easier.

When it comes to features, there is a lot to consider when evaluating various systems.  Here are some of the primary features that you may want to consider:

Reg Binder Format Template Set-up: The ability to set up your unique folder structure for your company’s regulatory binders that follow your specific company SOPs.

Document Versioning Control: The ability to track versions of documents.  For instance, protocol and ICF updates that show the succession of documents, oldest to newest, and prevents users from accidentally accessing an old version of a file for current use.

Document Expiration Tracking and Notifications: Having the ability to assign an expiration to a document and system notification to alert your staff that a document has expired and needs updating.

eSignatures: Part-11 Compliant eSignatures for all study documents including capturing multiple eSignatures on documents, Outlook eSignature integration capabilities, and mobile app eSignature capture.

Mobile App: A mobile app that allows staff to view all regulatory documents, eSign documents as requested, review study inclusion/exclusion on the go and refer subjects with a click of a button in the mobile app. (Download the RealTime Mobile App in the App Store or Google Play)

Outlook integration: An integration that allows your staff to connect directly with their eRegulatory system to drag and drop documents into the regulatory binders, eSign documents and more

Monitoring Portal (multiple role types) (query system): Having a monitor/auditor-specific portal for multiple monitors/auditors that allow for complete document review, issuance of queries that alert staff, and a way for staff to respond and resolve issued queries.  These portals allow monitors/auditors to have remote access to the eRegulatory binders which will cause your sponsors and CROs to fall in love with your eReg system.

Central Documents: A place to store non-study-specific documents such as temperature logs, company training, calibration records, etc.  Central documents should be easily pushed to study binders as-needed.

Staff Documents: A professional, educational, and training tracking system (PETS) to store the documents for each staff member, study provider, investigator etc.  These documents would include CVs, licenses, GCP training, IATA certifications and more and would easily be pushed into all studies that the staff member is associated with for view by monitors and auditors.  Of course, staff documents should also have version control and expiration dates tracked.

Subject Documents: A place to store subject-specific documents such as medical records, signed ICFs, and other study-specific subject documents.

Compliance with Part-11 and HIPAA:  In order to meet FDA Part-11 and HIPAA compliance, your eRegulatory system must provide several important features such as User Audit Trails, User Password Rules and Controls, Encryption of Data in motion and at rest, validated software, and compliant eSignatures, just to name a few. These are required and will be verified by the FDA and must be present during an audit.

Additionally, only a few eRegulatory systems on the market have third-party Part-11 review documentation that confirms that all of these requirements are met.  Don’t gamble your site’s integrity with a system that does NOT have a validated third-party assurance letter.

Communication/Integration with other systems: The last thing site personnel need is yet another portal to log into.  Will your site team have to launch into multiple systems to manage eRegulatory subject recruitment, CTMS, or pay accounts, each with a different username and password?  Having to function in multiple systems will put a strain not only on user experience but possibly work productivity itself.

The idea of using one system and one login to access all your sites needs is completely possible and being able to pair products and system integrations are key.

Customer Support: With the idea of pairing separate products and integrating systems together comes the need to access different software support teams. However, if you are using two different systems (i.e., CTMS and eRegulatory by different vendors) you will likely not enjoy the same level of integration and features that would come from having both systems in the same platform by the same vendor.  Your staff will also have to work in separate systems even if there is some level of integration for sign-on and data sharing.

Pricing, pricing, pricing! Maximizing cost-effectiveness also includes pricing. eRegulatory systems typically have a start-up, in addition to a per-study fee.  Those rates can possibly be adjusted depending on other products you use with the company or if you are contracted for a set amount of studies.

Contracts can be a bit tricky though.  Be aware of contracts that lock you into a lower rate for the per study fee but obligate you to use their system, whether you like the system or not, until you reach your set amount of studies.  Some systems charge annual storage fees per study, so over time you may be paying a very large annual fee for storage that will grow larger each year.  These storage fees can really add up so consider a system that has no annual storage fees!

When choosing an eRegulatory system consider asking for a demo to test the interface and the overall user experience. Be sure to inquire about possibilities of integrating with other systems and if they’ve had issues with connectivity in the past. If this is the case, ask how long it would take to solve said connectivity problems. Finally, before signing, look out for hidden storage fees or binding contracts.

Unparalleled user features and experience, great customer support, and competitive pricing are just a few of the advantages of RealTime-eDOCS for paperless eRegulatory. All of our solutions (CTMS, eDOCS, eSOURCE, TEXT and PAY) can be used as stand-alone systems or can fully-integrate with each other! If you are interested in learning more about our products call (210) 852-4310 or click HERE.

26 Oct 2017

eSOURCE…We changed the game, AGAIN!

The clinical research industry has inevitably been slow to adopt technological advances primarily due to regulatory constraints and a fear of change that could disrupt current processes.  While the regulatory guidance has been issued by the FDA, development of solutions that can conform to the guidance AND improve efficiency is challenging.

In the recent years, there has been a shift in favor of technology because software companies like RealTime have found a way to develop solutions that improve efficiency in a user-friendly environment and meet all the regulations needed to be used in the clinical research industry.

As a result of these advancements, RealTime has turned into a key player and trendsetter in the CTMS world.  During the 2017 Global Site Solutions Summit in Boca Raton, FL, RealTime showcased its newest solution, eSOURCE, which will revolutionize how sites collect study data and how sponsors and CROs review and transfer that data into EDC systems.  Further, RealTime is the only CTMS company that can integrate CTMS, eSOURCE, eDOCS, PAY and TEXT all into a single platform.  Sites that embrace these integrated solutions will experience unparalleled efficiencies.

eSOURCE like all the other RealTime solutions is capable of being used as a stand-alone system or can be fully integrated into other systems. Its comprehensive set of features give sites more features, greater scalability, and better support, all at an affordable price. RealTime-eSOURCE is also a fully-validated, Part-11 complaint system, so sites and sponsors can feel confident that it meets FDA regulations for electronic source data collection.

RealTime is committed to bringing new and innovative solutions to the clinical research industry that will enhance efficiencies, saving time and money and ultimately speeding up the process of delivering new medical therapies to the world.

Contact RealTime today if you would like to learn more about our solutions and/or set up a personalized demonstration of our systems.

 

 

 

14 Aug 2017

RealTime is Changing the CTMS Industry with First-of-its-Kind New App

Research sites can now access popular eDOCS solution on mobile device with new app

SAN ANTONIO—Want to access site eRegulatory files, sign documents with your thumb print, refer a patient to a study or look up site and sponsor contacts all on your mobile device? There’s an app for that!

RealTime-CTMS launched the first-of-its-kind new app this week that allows site staff to use its popular eDOCS solution from an iOS or Android device.

“No other CTMS or eRegulatory system has mobile capabilities like we do,” says RealTime-CTMS CEO, Rick Greenfield. “The ease at which sites can access pertinent information including inclusion and exclusion information, sign documents using finger print technology and even refer patients directly into the CTMS system can’t be matched.”

eDOCS is a cutting-edge system that can be fully integrated with RealTime-CTMS or used as a stand-alone system. The solution enables sites to go fully digital, eliminating messy regulatory binders and paper work. eDOCS has already made a splash in the clinical research world and with the release of the app, industry leaders are expecting the solution to continue to grow in popularity.

“Everything is going mobile, even the clinical trial industry,” says Greenfield. “With the tap of a button on your mobile device, sites now have instant access to information that would otherwise have to be found in bulky binders and loads of paperwork.”

Some features of the new app include the ability for investigators to sign documents using iOS and Android finger print technologies, easy access to site and sponsor contacts on the go and push notifications that alert investigative staff that requests for signatures are pending. The app also allows site staff to refer a patient into a study and instantly access protocol and study information.

“We are very excited about the launch of our app and believe it will greatly increase efficiency and success across our sites,” says Greenfield.

For more information on eDOCS mobile, download the app at the App Store or on Google Play.

About RealTime-CTMS

RealTime Software Solutions, LLC is located in San Antonio, TX and is a leader in database-driven, cloud-based clinical research software solutions. Our focus is on research sites and our goal is to solve problems and provide systems that make the sites more efficient and more profitable. We are constantly listening to our customers to provide new innovations that improve performance and help sites achieve their goals.

09 May 2016
FDA Part 11 Compliance Compliant

What is 21 CFR Part 11?

fda (3)With Part 11 compliant systems now available for investigator sites to streamline processes, some of us are wondering what exactly is 21 CFR Part 11 and why is it important?  Essentially, 21 CFR Part 11 regulations define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Basically, Part 11 allows companies to replace any paper record or hand written signature with an electronic record/signature.

For years now, computers have made individuals more productive while eliminating costs associated with paper-based systems. It’s natural that investigator sites are now wanting to replace paper with electronic records to boost efficiency.  The truth is, every investigator site already has electronic records but most companies are so unsure of Part 11 compliance that they resort to printing paper in fear of being non-compliant with regulations.  Instead of fearing Part 11, it’s much more beneficial to embrace these regulations and realize that Part 11 compliance is not complicated.  Can you imagine a research site with a lot less paper?  Not only does Part 11 make this possible, many research sites are already leading the way to an electronic future by adopting systems that manage their regulatory documentation electronically.

While Part 11 regulations are essential and helpful, many would argue that the actual document lacks detail on implementation.  With the lack of detail, the FDA has since provided guidance documents to assist in implementation and the industry has adopted standards to ensure compliance.

There are three primary areas of 21 CFR Part 11 compliance:

1) Standard Operating Procedures – The software vendor will have about 10 or more SOPs to address their IT infrastructure. These SOPs include, but are not limited to, Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures. It’s important for research sites to explore their own IT infrastructure to ensure SOPs that maintain compliance at the site level.

2) Computer system features – There are numerous standard product features that are implemented to ensure computer system security and data integrity. These features include complete audit trails, access controls, record retention and electronic signatures.

3) Computer System Validation – Part 11 compliant systems must have documented evidence that the system does what is intended. Furthermore, users should be trained to detect when the system is not working as intended.

Through Part 11 regulations, the FDA has paved the way to an electronic future for research sites.  Adopting a Part 11 system doesn’t take an act of faith but it does require a systematic approach to compliance.  If you want to see how other sites are ditching the paper regulatory binders and moving towards electronic freedom, visit our website to learn more about RealTime-eDOCS.  Better yet, contact us for an online demo to see the system in action!